2023
A multicenter phase Ib trial of the histone deacetylase inhibitor entinostat in combination with pembrolizumab in patients with myelodysplastic syndromes/neoplasms or acute myeloid leukemia refractory to hypomethylating agents
Bewersdorf J, Shallis R, Sharon E, Park S, Ramaswamy R, Roe C, Irish J, Caldwell A, Wei W, Yacoub A, Madanat Y, Zeidner J, Altman J, Odenike O, Yerrabothala S, Kovacsovics T, Podoltsev N, Halene S, Little R, Piekarz R, Gore S, Kim T, Zeidan A. A multicenter phase Ib trial of the histone deacetylase inhibitor entinostat in combination with pembrolizumab in patients with myelodysplastic syndromes/neoplasms or acute myeloid leukemia refractory to hypomethylating agents. Annals Of Hematology 2023, 103: 105-116. PMID: 38036712, DOI: 10.1007/s00277-023-05552-4.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityAcute myeloid leukemiaMarrow complete remissionPhase Ib trialAdverse eventsIb trialDose escalationNCI Cancer Therapy Evaluation ProgramAcute myeloid leukemia refractoryHematologic adverse eventsProtocol-defined responseDose level 1Anti-PD1 therapyAnti-PD1 antibodyDose-escalation designLimited clinical efficacySystems immunology approachHistone deacetylase inhibitor entinostatLeukemia refractoryMCR patientsComplete remissionRespiratory failureSuppressor cellsEscalation designClinical efficacyA randomized phase III study of standard versus high-dose cytarabine with or without vorinostat for AML
Garcia-Manero G, Podoltsev N, Othus M, Pagel J, Radich J, Fang M, Rizzieri D, Marcucci G, Strickland S, Litzow M, Savoie M, Medeiros B, Sekeres M, Lin T, Uy G, Powell B, Kolitz J, Larson R, Stone R, Claxton D, Essell J, Luger S, Mohan S, Moseley A, Appelbaum F, Erba H. A randomized phase III study of standard versus high-dose cytarabine with or without vorinostat for AML. Leukemia 2023, 38: 58-66. PMID: 37935977, DOI: 10.1038/s41375-023-02073-x.Peer-Reviewed Original ResearchConceptsHigh-dose cytarabineAcute myeloid leukemiaDose cytarabineRandomized phase III studyUnfavorable-risk cytogeneticsRandomized multicenter trialOverall remission ratePhase III studyHigh response rateHistone deacetylase inhibitorsInduction therapyFree survivalPrimary endpointRemission rateUntreated patientsIII studyOverall survivalYounger patientsMulticenter trialImproved outcomesMyeloid leukemiaCytogenetic subsetsCytarabineResponse rateHigh dosesStatin use, survival and incidence of thrombosis among older patients with polycythemia vera and essential thrombocythemia
Podoltsev N, Wang R, Shallis R, Stempel J, Di M, Neparidze N, Zeidan A, Huntington S, Giri S, Hull S, Gore S, Ma X. Statin use, survival and incidence of thrombosis among older patients with polycythemia vera and essential thrombocythemia. Cancer Medicine 2023, 12: 18889-18900. PMID: 37702132, PMCID: PMC10557879, DOI: 10.1002/cam4.6528.Peer-Reviewed Original ResearchConceptsIncidence of thrombosisPolycythemia veraEssential thrombocythemiaStatin useOlder adultsEnd Results-Medicare databasePopulation-based cohort studyArterial thrombotic eventsSurvival of patientsUse of statinsClaims-based studyRisk of thrombosisCardiovascular morbidityCause mortalityTreatment weighting (IPTW) approachCohort studyOlder patientsOverall survivalThrombotic eventsVenous thrombosisPatient populationPrevious registryStatinsTherapeutic strategiesET subgroupOlder patients with chronic myeloid leukemia face suboptimal molecular testing and tyrosine kinase inhibitor adherence
Shallis R, Wang R, Zeidan A, Huntington S, Neparidze N, Stempel J, Mendez L, Di M, Ma X, Podoltsev N. Older patients with chronic myeloid leukemia face suboptimal molecular testing and tyrosine kinase inhibitor adherence. Blood Advances 2023, 7: 3213-3224. PMID: 36939371, PMCID: PMC10338212, DOI: 10.1182/bloodadvances.2022009074.Peer-Reviewed Original ResearchConceptsChronic myeloid leukemiaTKI adherenceTKI initiationOlder patientsMyeloid leukemiaEnd Results-Medicare databaseTyrosine kinase inhibitor usePolymerase chain reaction testingQuantitative polymerase chain reaction testingOlder patient populationCare of patientsHealth care accessReal-world studyReal-world evidenceLow socioeconomic statusLow-income subsidyFirst yearInfluenza vaccinationInhibitor useWorse survivalTKI treatmentMultivariable analysisPatient populationOptimal monitoringCare accessGilteritinib in Combination With Induction and Consolidation Chemotherapy and as Maintenance Therapy: A Phase IB Study in Patients With Newly Diagnosed AML
Pratz K, Cherry M, Altman J, Cooper B, Podoltsev N, Cruz J, Lin T, Schiller G, Jurcic J, Asch A, Wu R, Hill J, Gill S, James A, Rich E, Hasabou N, Perl A, Levis M. Gilteritinib in Combination With Induction and Consolidation Chemotherapy and as Maintenance Therapy: A Phase IB Study in Patients With Newly Diagnosed AML. Journal Of Clinical Oncology 2023, 41: 4236-4246. PMID: 37379495, DOI: 10.1200/jco.22.02721.Peer-Reviewed Original ResearchConceptsPhase Ib studyMaintenance therapyConsolidation chemotherapyDose escalationFLT3 inhibitorsIb studyHigh-dose cytarabine consolidationMedian overall survival timeSingle-agent maintenance therapyComplete response rateHigher trough levelsOverall survival timeCytarabine consolidationChemotherapy regimenDose expansionAdult patientsIntensive inductionTrough levelsCount recoveryMedian timeRandomized trialsInduction cyclesSurvival timeDay 1Response rateSupportive Care for Patients With Myelodysplastic Syndromes
Stempel J, Podoltsev N, Dosani T. Supportive Care for Patients With Myelodysplastic Syndromes. The Cancer Journal 2023, 29: 168-178. PMID: 37195773, DOI: 10.1097/ppo.0000000000000661.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsMyelodysplastic syndromeMyeloid leukemiaLow-risk diseaseTreatment-related complicationsSupportive care interventionsSupportive care measuresAcute myeloid leukemiaBone marrow disordersAntimicrobial prophylaxisFrequent complicationProgressive cytopeniasSupportive careTransfusion supportHigh-risk counterpartsBetter prognosisPalliative careRoutine immunizationCare measuresCare interventionsIneffective hematopoiesisIron overloadCommon causeMarrow disordersSyndrome populationPatientsImpact of Prophylactic Antibacterials on Coagulation Profiles and Bleeding in Patients with Acute Myeloid Leukemia/Myelodysplastic Syndrome
Allen C, Gautam S, Cheng W, Pine A, Podoltsev N, Zeidan A, Lee A, Shallis R. Impact of Prophylactic Antibacterials on Coagulation Profiles and Bleeding in Patients with Acute Myeloid Leukemia/Myelodysplastic Syndrome. Acta Haematologica 2023, 146: 287-292. PMID: 37166332, DOI: 10.1159/000530153.Peer-Reviewed Original ResearchConceptsAML/myelodysplastic syndromeAcute myeloid leukemiaInternational normalized ratioAntibacterial prophylaxisMyelodysplastic syndromeProphylactic antibacterialsCoagulation profileAcute myeloid leukemia/myelodysplastic syndromeDiagnosis of AMLHigher international normalized ratioLeukemia/myelodysplastic syndromePartial thromboplastin time prolongationYale-New Haven HospitalYale-New HavenRetrospective cohort studyAbnormal coagulation profileGroup of patientsTime of admissionHigh rateIndividual patient encountersInstitutional review boardAntibacterial exposureRelevant bleedingAdult patientsCohort studySecond malignancies among older patients with classical myeloproliferative neoplasms treated with hydroxyurea
Wang R, Shallis R, Stempel JM, Huntington SF, Zeidan AM, Gore SD, Ma X, Podoltsev NA. Second malignancies among older patients with classical myeloproliferative neoplasms treated with hydroxyurea. Blood Advances 2023, 7: 734-743. PMID: 35917456, PMCID: PMC9989521, DOI: 10.1182/bloodadvances.2022008259.Peer-Reviewed Original ResearchConceptsSecond malignanciesAcute myeloid leukemiaOlder patientsMyelodysplastic syndromeMyeloproliferative neoplasmsHU usersHigh riskPolycythemia veraEssential thrombocythemiaRisk of SMAML/myelodysplastic syndromeClassical Philadelphia chromosome-negative myeloproliferative neoplasmsImpact of hydroxyureaRetrospective cohort studyUse of hydroxyureaPhiladelphia chromosome-negative myeloproliferative neoplasmsClassical myeloproliferative neoplasmsCumulative incidence probabilityCohort studyCytoreductive therapyPatient characteristicsMedian ageHU useMyeloid leukemiaSecondary myelofibrosisTreatment patterns and real-world effectiveness of rituximab maintenance in older patients with mantle cell lymphoma: a population-based analysis
Di M, Long J, Kothari S, Sethi T, Zeidan A, Podoltsev N, Shallis R, Wang R, Ma X, Huntington S. Treatment patterns and real-world effectiveness of rituximab maintenance in older patients with mantle cell lymphoma: a population-based analysis. Haematologica 2023, 108: 2218-2223. PMID: 36655436, PMCID: PMC10388284, DOI: 10.3324/haematol.2022.282252.Peer-Reviewed Original Research
2022
Outcomes in Patients with FLT3-Mutated Relapsed/ Refractory Acute Myelogenous Leukemia Who Underwent Transplantation in the Phase 3 ADMIRAL Trial of Gilteritinib versus Salvage Chemotherapy
Perl A, Larson R, Podoltsev N, Strickland S, Wang E, Atallah E, Schiller G, Martinelli G, Neubauer A, Sierra J, Montesinos P, Recher C, Yoon S, Maeda Y, Hosono N, Onozawa M, Kato T, Kim H, Hasabou N, Nuthethi R, Tiu R, Levis M. Outcomes in Patients with FLT3-Mutated Relapsed/ Refractory Acute Myelogenous Leukemia Who Underwent Transplantation in the Phase 3 ADMIRAL Trial of Gilteritinib versus Salvage Chemotherapy. Transplantation And Cellular Therapy 2022, 29: 265.e1-265.e10. PMID: 36526260, PMCID: PMC10189888, DOI: 10.1016/j.jtct.2022.12.006.Peer-Reviewed Original ResearchConceptsHematopoietic stem cell transplantationAcute myelogenous leukemiaPost-transplantation maintenance therapyLower relapse rateAdverse eventsADMIRAL trialMaintenance therapyPost-transplantation survivalGilteritinib armRelapse rateSalvage chemotherapyMyelogenous leukemiaRefractory acute myelogenous leukemiaTreatment-emergent adverse eventsFLT3 internal tandem duplication (ITD) mutationsCommon adverse eventsComposite complete remissionGlobal phase 3Incidence of gradePost-transplantation complicationsTransplantation-eligible patientsAlanine aminotransferase levelsHigher remission ratesOverall survival rateSurvival of patientsCost-effectiveness of azacitidine and ivosidenib in newly diagnosed older, intensive chemotherapy-ineligible patients with IDH1-mutant acute myeloid leukemia
Bewersdorf J, Patel K, Goshua G, Shallis R, Podoltsev N, Stahl M, Stein E, Huntington S, Zeidan A. Cost-effectiveness of azacitidine and ivosidenib in newly diagnosed older, intensive chemotherapy-ineligible patients with IDH1-mutant acute myeloid leukemia. Leukemia & Lymphoma 2022, 64: 454-461. PMID: 36493798, PMCID: PMC9957935, DOI: 10.1080/10428194.2022.2140288.Peer-Reviewed Original ResearchTreatment of myelodysplasia‐associated reactive, non‐interstitial granulomatous dermatitis with hydroxychloroquine
Choi R, Bhullar S, Glusac E, Podoltsev N, Leventhal J. Treatment of myelodysplasia‐associated reactive, non‐interstitial granulomatous dermatitis with hydroxychloroquine. International Journal Of Dermatology 2022, 62: e398-e399. PMID: 36214463, DOI: 10.1111/ijd.16441.Peer-Reviewed Case Reports and Technical NotesBias Against International Medical Graduates in the Hematology/Oncology Fellowship Recruitment Process: Findings From a Nationwide Survey of Fellowship Program Directors
Butt A, Mankbadi M, Erikson C, Marshall A, Masselink LE, Tong G, Hafler J, Podoltsev N, Lee AI. Bias Against International Medical Graduates in the Hematology/Oncology Fellowship Recruitment Process: Findings From a Nationwide Survey of Fellowship Program Directors. JCO Oncology Practice 2022, 18: 783-787. PMID: 36108253, DOI: 10.1200/op.22.00219.Peer-Reviewed Original ResearchMyeloproliferative Neoplasms, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology.
Gerds A, Gotlib J, Ali H, Bose P, Dunbar A, Elshoury A, George T, Gundabolu K, Hexner E, Hobbs G, Jain T, Jamieson C, Kaesberg P, Kuykendall A, Madanat Y, McMahon B, Mohan S, Nadiminti K, Oh S, Pardanani A, Podoltsev N, Rein L, Salit R, Stein B, Talpaz M, Vachhani P, Wadleigh M, Wall S, Ward D, Bergman M, Hochstetler C. Myeloproliferative Neoplasms, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology. Journal Of The National Comprehensive Cancer Network 2022, 20: 1033-1062. PMID: 36075392, DOI: 10.6004/jnccn.2022.0046.Peer-Reviewed Original ResearchConceptsNCCN Clinical Practice GuidelinesMyeloproliferative neoplasmsClinical practice guidelinesEssential thrombocythemiaPolycythemia veraRisk stratificationManagement of myeloproliferative neoplasmsOverproduction of blood cellsPhiladelphia chromosome-negative myeloproliferative neoplasmsDiagnosis of myeloproliferative neoplasmsPractice guidelinesClonal blood disorderManagement of myelofibrosisCourse of treatmentSupportive care strategiesAssessment of symptomsNCCN GuidelinesDiagnostic workupCare strategiesMultidisciplinary panelBlood disordersHeterogeneous groupSymptom statusBlood cellsNCCNConcealed by the convenient: acquired von Willebrand syndrome in myeloproliferative neoplasm requires a thorough evaluation
Stempel JM, Podoltsev NA, Zeidan AM, Lee AI, Shallis RM. Concealed by the convenient: acquired von Willebrand syndrome in myeloproliferative neoplasm requires a thorough evaluation. Annals Of Hematology 2022, 101: 2559-2561. PMID: 35984499, DOI: 10.1007/s00277-022-04943-3.Peer-Reviewed Case Reports and Technical NotesChanges in multiple myeloma treatment patterns during the early COVID-19 pandemic period
Neparidze N, Wang R, Zeidan AM, Podoltsev NA, Shallis RM, Ma X, Davidoff AJ, Huntington SF. Changes in multiple myeloma treatment patterns during the early COVID-19 pandemic period. Leukemia 2022, 36: 2136-2139. PMID: 35761025, PMCID: PMC9243711, DOI: 10.1038/s41375-022-01633-x.Peer-Reviewed Original ResearchAnagrelide for platelet-directed cytoreduction in polycythemia vera: Insights into utility and safety outcomes from a large multi-center database
Rippel N, Tremblay D, Zubizarreta N, Podoltsev N, Gotlib J, Heaney M, Kuykendall A, O'Connell C, Shammo JM, Fleischman A, Kremyanskaya M, Hoffman R, Mesa R, Yacoub A, Mascarenhas J. Anagrelide for platelet-directed cytoreduction in polycythemia vera: Insights into utility and safety outcomes from a large multi-center database. Leukemia Research 2022, 119: 106903. PMID: 35717689, DOI: 10.1016/j.leukres.2022.106903.Peer-Reviewed Original ResearchConceptsPolycythemia veraHigh-risk essential thrombocythemiaHigh-risk polycythemia veraLarge multi-centre databaseGuideline-directed managementUse of anagrelideMedian platelet countMulti-center cohortMulti-center databaseVon Willebrand diseaseANA therapyPrior thrombosisTolerability profileCytoreductive agentsMedian durationArterial thrombosesExtreme thrombocytosisPlatelet countTherapeutic endpointsSafety outcomesAnagrelideEssential thrombocythemiaClinical practicePatientsPlatelet controlFollow-up of patients with R/R FLT3-mutation–positive AML treated with gilteritinib in the phase 3 ADMIRAL trial
Perl AE, Larson RA, Podoltsev NA, Strickland S, Wang ES, Atallah E, Schiller GJ, Martinelli G, Neubauer A, Sierra J, Montesinos P, Récher C, Yoon SS, Hosono N, Onozawa M, Chiba S, Kim HJ, Hasabou N, Lu Q, Tiu R, Levis MJ. Follow-up of patients with R/R FLT3-mutation–positive AML treated with gilteritinib in the phase 3 ADMIRAL trial. Blood 2022, 139: 3366-3375. PMID: 35081255, PMCID: PMC9197557, DOI: 10.1182/blood.2021011583.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaSalvage chemotherapyADMIRAL trialSC armOverall survivalFLT3 mutation-positive acute myeloid leukemiaPositive acute myeloid leukemiaComposite complete remissionStable safety profileAdverse event incidenceCommon adverse eventsLiver transaminase levelsMedian overall survivalSuperior overall survivalLong-term treatment effectsGilteritinib armComplete remissionMaintenance therapyAdverse eventsCumulative incidenceMedian survivalTransaminase levelsEvent incidenceMaintenance treatmentSafety profileSurvival of mantle cell lymphoma in the era of Bruton tyrosine kinase inhibitors: a population-based analysis
Di M, Cui C, Kothari S, Zeidan AM, Podoltsev NA, Neparidze N, Shallis R, Wang R, Ma X, Huntington SF. Survival of mantle cell lymphoma in the era of Bruton tyrosine kinase inhibitors: a population-based analysis. Blood Advances 2022, 6: 3339-3342. PMID: 35240689, PMCID: PMC9198937, DOI: 10.1182/bloodadvances.2021006934.Peer-Reviewed Original ResearchClinical outcomes in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia treated with gilteritinib who received prior midostaurin or sorafenib
Perl AE, Hosono N, Montesinos P, Podoltsev N, Martinelli G, Panoskaltsis N, Recher C, Smith CC, Levis MJ, Strickland S, Röllig C, Groß-Langenhoff M, Chou WC, Lee JH, Yokoyama H, Hasabou N, Lu Q, Tiu RV, Altman JK. Clinical outcomes in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia treated with gilteritinib who received prior midostaurin or sorafenib. Blood Cancer Journal 2022, 12: 84. PMID: 35637252, PMCID: PMC9151663, DOI: 10.1038/s41408-022-00677-7.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaFLT3-TKIRefractory FLT3TKI exposureSalvage chemotherapyClinical outcomesMyeloid leukemiaR AMLLonger median overall survivalComposite complete remissionHigher CRCS ratesMedian overall survivalTyrosine kinase inhibitor midostaurinKinase inhibitor midostaurinPotential clinical impactADMIRAL trialCRC ratesGilteritinib armPrior sorafenibComplete remissionRemission durationOverall survivalTKI therapyTKI useSurvival outcomes